Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Essenz HLM (Heart-Lung Machine) Recalled by LivaNova Deutschland GmbH Due to Heart-Lung Machine GUI touchscreen may go dark for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LivaNova Deutschland GmbH directly.
Affected Products
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
Quantity: 38
Why Was This Recalled?
Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LivaNova Deutschland GmbH
LivaNova Deutschland GmbH has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report